Galvus Met® (Galvus Met) > Kev khomob thiab kev tiv thaiv

Zaj duab xis-coated ntsiav tshuaj	1 tab.
yam tshuaj:
vildagliptin	50 mg
metformin hydrochloride	500 mg
850 mg
1000 mg
tus zam: hyprolose - 49.5 / 84.15 / 99 mg, magnesium stearate - 6.5 / 9.85 / 11 mg, hypromellose - 12.858 / 18.58 / 20 mg, titanium dioxide (E171) - 2.36 / 2, 9 / 2.2 mg, macrogol 4000 - 1.283 / 1.86 / 2 mg, talc - 1.283 / 1.86 / 2 mg, hlau oxide daj (E172) - 0.21 / 0.82 / 1.8 mg, hlau oxide liab (E172) - 0.006 mg / - / -

Kev piav qhia ntawm daim ntawv tshuaj

Ntsiav tshuaj, 50 mg + 500 mg: oval, nrog beveled sawv, them nrog ib zaj duab xis membrane ntawm lub teeb daj nrog ib tug me pinkish zas. Cov cim NVR yog nyob rau ib sab thiab LLO yog nyob rau lwm qhov.

Ntsiav tshuaj, 50 mg + 850 mg: oval, nrog beveled sawv, them nrog ib zaj duab xis membrane ntawm daj nrog ib tug tsis muaj zog greyish zas. Ntawm ib sab yog kos "NVR", nyob rau lwm qhov - "SEH".

Ntsiav tshuaj, 50 mg + 1000 mg: oval, nrog beveled sawv, them nrog zaj duab xis daim nyias nyias ntawm tsaus daj nrog lub greyish zas. Muaj “NVR” cim rau ib sab thiab “FLO” nyob rau lwm yam.

Cov Tshuaj Hauv Tshuaj

Cov sib xyaw ua ke ntawm cov tshuaj Galvus Met suav nrog 2 hypoglycemic cov neeg sawv cev nrog cov txheej txheem sib txawv ntawm kev ua: vildagliptin, koom nrog cov chav kawm ntawm dipeptidyl peptidase-4 inhibitors (DPP-4), thiab metformin (hauv daim ntawv ntawm hydrochloride), tus sawv cev ntawm chav kawm biguanide. Kev sib xyaw ua ke ntawm cov khoom no tso cai rau koj kom tswj tau cov ntshav qabzib ntau hauv cov neeg mob ntshav qab zib hom 2 rau 24 teev.

Vildagliptin, tus sawv cev ntawm chav kawm ntawm stimulators ntawm insular pancreatic apparatus, xaiv rau kev cuam tshuam cov enzyme DPP-4, uas rhuav tshem hom 1 glucagon-zoo li peptide (GLP-1) thiab glucose-dependant insulinotropic polypeptide (HIP).

Metformin txo cov khoom nyob hauv qabzib los ntawm daim siab, txo qhov nqus ntawm cov piam thaj hauv qhov hnyuv thiab txo cov tshuaj insulin los ntawm kev txhim kho thiab kev siv cov kua nplaum los ntawm cov ntaub so ntswg.

Metformin tsim tawm cov khoom sib xyaw ua ke glycogen nrog los ntawm kev ua yeeb yam ntawm glycogen synthetase thiab txhim kho cov qabzib thauj los ntawm qee yam cov qog ua rau transporter protein (GLUT-1 thiab GLUT-4).

Kev txwv ceev thiab ua tiav ntawm DPP-4 kev ua haujlwm tom qab vildagliptin ua rau muaj kev nce ntxiv hauv ob qho tib si hauv paus thiab zaub mov zais cia ntawm GLP-1 thiab HIP los ntawm cov hnyuv mus rau hauv cov kab ke hauv txhua hnub.

Ua rau kev nce siab ntawm GLP-1 thiab HIP, vildagliptin ua rau muaj kev nkag siab zoo ntxiv ntawm pancreatic cells-hlwb rau cov piam thaj, uas ua rau muaj kev txhim kho hauv cov kua dej-npauj insulin secretion. Qeb kev txhim kho ntawm kev ua haujlwm ntawm β-hlwb yog nyob ntawm qhov kev puas tsuaj ntawm lawv thawj zaug kev puas tsuaj, yog li ntawd rau cov tib neeg tsis muaj ntshav qab zib mellitus (nrog ib qho kev sib xyaw ntawm cov piam thaj hauv ntshav plasma), vildagliptin tsis txhawb cov tshuaj insulin secretion thiab tsis txo cov ntshav qabzib.

Los ntawm kev nce siab ntawm cov endogenous GLP-1, vildagliptin tsub kom lub hlwb α-hlwb rau cov kua nplaum ntev, uas ua rau muaj kev txhim kho hauv cov kua nplaum-raws li kev cai ntawm glucagon secretion. Kev txo qis hauv cov ntshav qabzib hauv siab tom qab noj mov, nyeg, ua rau muaj kev poob qis hauv cov tshuaj insulin.

Kev nce ntxiv ntawm qhov sib piv ntawm insulin / glucagon tiv thaiv keeb kwm ntawm hyperglycemia, vim qhov nce ntawm cov concentration ntawm GLP-1 thiab HIP, ua rau muaj kev txo qis ntawm cov piam thaj ntau ntau los ntawm lub siab ob qho tib si thaum thiab tom qab noj mov, uas ua rau txo qis hauv cov concentration ntawm cov piam thaj hauv ntshav plasma.

Tsis tas li ntawd, tawm tsam cov keeb kwm yav dhau los ntawm kev siv vildagliptin, qhov kev txo qis ntawm cov concentration ntawm lipids hauv cov ntshav ntshav tom qab noj mov tau sau tseg, txawm li cas los xij, cov nyhuv no tsis cuam tshuam nrog nws cov nyhuv ntawm GLP-1 lossis HIP thiab kev txhim kho ntawm kev ua haujlwm ntawm pancreatic islet hlwb.

Nws paub tias nce ntxiv ntawm qhov kev nkag siab ntawm GLP-1 tuaj yeem ua rau lub ntsej muag qis dua ntawm lub plab, txawm li cas los xij, tiv thaiv keeb kwm ntawm kev siv vildagliptin, cov txiaj ntsig zoo li tsis pom.

Thaum siv vildagliptin hauv 5759 cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus rau 52 lub lis piam li monotherapy lossis kev sib xyaw nrog metformin, sulfonylurea derivatives, thiazolidinedione, lossis insulin, qhov tseem ceeb uas yuav txo tau ntev ntev hauv kev saib xyuas ntawm glycated hemoglobin (НbА) tau pom._1s) thiab yoo ntshav cov kua nplaum.

Metformin pab kho cov ntshav qabzib nyob hauv cov neeg mob ntshav qab zib hom 2 los ntawm kev txo qis ntshav muaj ntshav qab zib ntau ua ntej thiab tom qab noj mov.

Tsis zoo li sulfonylurea derivatives, metformin tsis ua rau cov ntshav qog ntshav qab zib hauv cov neeg mob ntshav qab zib hom 2 ntshav qab zib lossis cov neeg muaj kev noj qab haus huv (tshwj tsis yog qee kis tshwj xeeb). Kev kho nrog cov tshuaj tsis ua rau kev loj hlob ntawm hyperinsulinemia. Nrog rau kev siv cov metformin, insulin secretion tsis hloov, thaum lub sij hawm insulin ntau nyob rau hauv cov ntshav ntawm lub plab tas thiab thaum nruab hnub nws yuav txo qis.

Thaum siv cov metformin, muaj txiaj ntsig zoo rau cov metabolism ntawm lipoproteins raug sau tseg: kev txo qis hauv kev ua si ntawm cov roj (cholesterol) tag nrho, LDL cov roj (cholesterol) thiab triglycerides, tsis cuam tshuam nrog cov nyhuv ntawm cov tshuaj ntawm cov concentration ntawm cov piam thaj hauv ntshav plasma.

Thaum siv kev sib xyaw ua ke nrog vildagliptin thiab metformin hauv koob tshuaj txhua hnub ntawm 1,500–3,000 mg ntawm metformin thiab 50 mg ntawm vildagliptin 2 zaug hauv ib hnub rau 1 xyoo, ib qho kev tshawb pom tseem ceeb txo qis hauv cov ntshav qabzib cov ntsiab lus tau pom (txiav txim los ntawm HbA qhov ntsuas qis_1s) thiab kev nce ntxiv hauv qhov feem ntawm cov neeg mob uas txo qis HbA concentration_1s nws muaj tsawg kawg 0.6-0.7% (piv nrog pab pawg ntawm cov neeg mob uas txuas ntxiv tau txais tsuas yog metformin).

Hauv cov neeg mob uas tau txais kev sib xyaw ntawm vildagliptin thiab metformin, qhov kev ntsuas pom hnyav hauv lub cev nyhav piv nrog thawj zaug hauv lub xeev tsis tau pom. 24 lub lis piam tom qab pib kho, hauv cov pab pawg ntawm cov neeg mob uas tau txais vildagliptin sib xyaw nrog metformin, muaj kev txo ntshav siab thiab txiv rau cov neeg mob ntshav siab.

Thaum siv kev sib xyaw ntawm vildagliptin thiab metformin yog kev pib kho mob rau cov neeg mob ntshav qab zib hom 2 mob ntshav qab zib, qhov tshuaj tiv thaiv tsis txaus siab hauv HbA tau pom nyob rau 24 lub lis piam_1s hauv kev sib piv nrog cov tshuaj tua kab mob nrog cov tshuaj no. Cov neeg mob ntshav qab zib tsawg tsawg nyob rau ob pawg kho mob.

Thaum siv vildagliptin (50 mg 2 zaug hauv ib hnub) nrog / tsis muaj metformin ua ke nrog insulin (koob tshuaj nruab nrab - 41 PIECES) hauv cov neeg mob hauv kev soj ntsuam, HbA qhov taw qhia_1s cov lus pom tseeb tsawg dua - los ntawm 0.72% (qhov ntsuas pib - qhov nruab nrab ntawm 8,8%). Qhov tshwm sim ntawm cov ntshav qog nqaij ntshav hauv pawg kho mob tau coj los piv rau kev tshwm sim ntawm kev mob ntshav qab zib hauv cov pab pawg placebo.

Thaum siv vildagliptin (50 mg 2 zaug hauv ib hnub) ua ke nrog metformin (≥1500 mg) ua ke nrog glimepiride (mg4 mg / hnub) hauv cov neeg mob hauv kev soj ntsuam, HbA qhov taw qhia_1s cov lus pom zoo tsawg - los ntawm 0.76% (los ntawm nruab nrab - 8.8%).

Cov Tshuaj Pharmacokinetics

Xuas. Thaum noj ntawm lub plab tas, vildagliptin yog nqus sai, T_max - 1.75 teev tom qab kev tswj hwm. Nrog rau kev noj zaub mov zoo ib txhij, tus nqi ntawm kev nqus ntawm vildagliptin tsawg zuj zus: muaj ib qho cuam tshuam hauv C_max 19% thiab nce rau hauv T_max txog li 2.5 teev .Txawm li cas los xij, kev noj mov tsis cuam tshuam rau qib ntawm kev nqus thiab AUC.

Vildagliptin tau nrawm nrawm, thiab nws qhov tseeb txog kev noj qab haus huv tom qab kev tswj hwm ntawm qhov ncauj yog 85%. C_max thiab AUC hauv kev kho mob ntau ntxiv nce ntxiv kwv yees qhov sib npaug ntawm cov koob tshuaj.

Kev xa Khoom. Qhov qib ntawm khi ntawm vildagliptin rau cov ntshav plasma tsawg (9.3%). Cov tshuaj no tau faib tawm ncaj nruab nrab ntawm cov ntshav thiab cov ntshav liab. Vildagliptin kev faib tawm tshwm sim txawm tias yog extravascularly, V_ss tom qab iv tswj yog 71 litres.

Kev zom zaub mov. Biotransformation yog qhov tseem ceeb ntawm kev zam ntawm vildagliptin. Hauv tib neeg lub cev, 69% ntawm cov tshuaj ntawm cov tshuaj yog hloov pauv. Lub ntsiab tshuaj tiv thaiv kab mob, LAY151 (57% ntawm qhov koob tshuaj), yog tshuaj pharmacologically tsis ua haujlwm thiab yog ib yam khoom ntawm cov hydrolysis ntawm cyanocomponent. Txog 4% ntawm cov koob tshuaj ntawm cov tshuaj undergo amide hydrolysis.

Hauv kev sim tshuaj, qhov ua tau zoo ntawm DPP-4 ntawm kev hloov kho cov tshuaj hydrolysis. Vildagliptin tsis yog metabolized nrog kev koom tes ntawm cytochrome P450 isoenzymes. Raws li kev tshawb fawb hauv vitro , vildagliptin tsis yog qhov tseem ceeb ntawm P450 isoenzymes, tsis inhibit thiab tsis ntxias cytochrome P450 isoenzymes.

Chaw Sau Ntawv. Tom qab noj cov tshuaj, kwv yees li 85% ntawm cov koob tshuaj yog ua rau lub raum thiab 15% dhau los ntawm txoj hnyuv, lub raum ua rau tsis muaj qhov hloov pauv vildagliptin yog 23%. Nrog rau / hauv kev qhia txog ntawm qhov nruab nrab T_1/2 nce mus txog 2 teev, tag nrho cov ntshav ntxuav thiab rov ua haujlwm ntawm vildagliptin yog 41 thiab 13 l / h, feem. T_1/2 tom qab noj tau ntev li 3 teev, tsis hais noj ntau npaum li cas.

Cov pab pawg neeg tshwj xeeb

Tus tub los ntxhais, lub cev ua kom loj thiab ntau haiv neeg tsis muaj kev cuam tshuam cov pharmacokinetics ntawm vildagliptin.

Lub siab ua haujlwm tsis zoo. Hauv cov neeg mob uas muaj lub siab ua haujlwm tsis txaus siab ntawm qhov mob me mus rau mob hnyav (6-10 cov ntsiab lus raws li kev faib menyuam yaus-Pugh), tom qab siv ib cov tshuaj, muaj qhov txo qis hauv bioavailability ntawm vildagliptin los ntawm 8 thiab 20%, feem. Hauv cov neeg mob uas lub siab ua rau lub siab ua txhaum loj (12 cov ntsiab lus raws li kev faib menyuam yaus-Pugh), kev siv lub cev ntawm vildagliptin nce ntxiv txog 22%. Qhov hloov siab tshaj plaws hauv lub bioavailability ntawm vildagliptin, nce ntxiv lossis txo qis li nruab nrab txog 30%, tsis yog qhov tseem ceeb hauv thaj chaw kho mob. Ib qho kev sib txuam ntawm qhov hnyav ntawm lub siab ua haujlwm tsis zoo thiab kev siv lub cev hluav taws xob tsis raug kuaj.

Lub raum khiav tsis zoo. Hauv cov neeg mob uas lub raum tsis ua haujlwm, me me, nruab nrab, lossis hnyav AUC, vildagliptin tau nce 1.4, 1.7, thiab 2 zaug piv nrog qhov ntsuas no hauv cov neeg ua haujlwm noj qab haus huv zoo, feem. AUC ntawm cov metabolite LAY151 nce 1.6, 3.2 thiab 7.3 npaug, thiab cov metabolite BQS867 nce 1.4, 2.7 thiab 7.3 npaug hauv cov neeg mob tsis zoo lub raum kev ua haujlwm ntawm mob me, nruab nrab thiab hnyav, feem. Cov ntaub ntawv tsis tshua muaj tsawg hauv cov neeg mob uas mob raum (raum), mob raum (CKD) qhia tias qhov ntsuas ntawm pawg no zoo ib yam li cov neeg mob raum tsis zoo. Qhov kev sib zog ntawm LAY151 metabolite hauv cov neeg mob thaum kawg-theem CKD tau nce ntau dua 2-3 zaug piv nrog qhov kev suav ntawm cov neeg mob uas muaj mob raum tsis zoo. Kev tshem ntawm vildagliptin lub sijhawm hemodialysis muaj kev txwv (3% thaum tus txheej txheem ntev tshaj li 3-4 teev 4 teev tom qab ib koob).

Cov neeg mob ≥65 xyoo. Qhov siab tshaj plaws ntawm kev nyab xeeb hauv cov tshuaj ntawm 32% (nce C_max 18%) hauv cov neeg mob laus dua 70 tsis yog qhov tseem ceeb hauv tsev kho mob thiab tsis cuam tshuam qhov inhibition ntawm DPP-4.

Cov neeg mob ≤18 xyoo. Cov teeb meem pharmacokinetic ntawm vildagliptin hauv cov menyuam yaus thiab cov neeg hluas hnub nyoog qis dua 18 xyoo tsis tau teeb tsa.

Xuas. Qhov ua tsis taus pa ntawm metformin thaum noj ntawm 500 mg rau ntawm ib qho khoob yog 50-60%. T_max hauv ntshav - 1.81 1.82.69 teev tom qab kev tswj hwm. Nrog rau qhov nce ntxiv ntawm cov tshuaj ntawm 500 mus rau 1500 mg lossis hauv koob tshuaj ntawm 850 txog 2250 mg sab hauv, qhov nce qeeb hauv kev tso tshuaj pharmacokinetic tau sau tseg (tshaj li yuav xav kom muaj txoj kev sib raug zoo). Cov nyhuv no tshwm sim tsis yog ntau los ntawm kev hloov pauv ntawm kev tshem tawm cov tshuaj ib yam li los ntawm kev poob qis hauv nws txoj kev nqus. Tawm tsam keeb kwm yav dhau los ntawm kev noj zaub mov, qhov degree thiab tus nqi ntawm nqus ntawm metformin kuj poob qis me ntsis. Yog li, nrog ib koob tshuaj ib zaug ntawm cov tshuaj ntawm 850 mg, qhov kev txo qis hauv C tau pom nrog zaub mov_max thiab AUC los ntawm 40 thiab 25% thiab nce T_max rau 35 feeb Cov chaw kab mob tseem ceeb ntawm cov ntsiab lus no tseem tsis tau txhim tsa.

Kev xa Khoom. Nrog ib zaug rau qhov ncauj ntawm 850 mg, pom meej V_d metformin yog (654 ± 358) l. Cov tshuaj yeeb yaj kiab tsis khi rau cov protein plasma, thaum sulfonylurea derivatives khi rau lawv ntau dua 90%. Metformin nkag mus rau cov ntshav liab (tej zaum yuav ntxiv dag zog rau txoj kev no dhau mus). Thaum siv metformin raws li tus txheej txheem (qhov koob tshuaj thiab zaus ntawm kev tswj hwm) C_ss Cov tshuaj nyob rau hauv cov ntshav ntshav tau mus txog hauv 24–48 teev thiab, raws li txoj cai, tsis pub tshaj 1 μg / ml. Hauv kev tswj xyuas kab mob kev nkeeg ntawm C_max ntshav metformin tsis tshaj 5 mcg / ml (txawm tias thaum noj ntau npaum).

Kev zom zaub mov. Nrog txoj kev tswj hwm ib leeg ntawm metformin rau cov neeg ua haujlwm noj qab haus huv, nws raug nteg tawm los ntawm lub raum tsis hloov. Hauv qhov no, cov tshuaj tsis tau metabolized hauv daim siab (tsis muaj cov tshuaj metabolites hauv tib neeg) thiab tsis tawm hauv cov kua tsib.

Chaw Sau Ntawv. Txij li thaum lub raum tshem tawm ntawm metformin yog kwv yees li 3.5 npaug siab dua ntawm creatinine tshem tawm, txoj kev tseem ceeb ntawm kev tshem tawm cov tshuaj yog tubular zais cia. Thaum noj, kwv yees li 90% ntawm qhov tshuaj uas tau nqus tau yog tso tawm los ntawm lub raum thaum thawj 24 teev, nrog T_1/2 los ntawm cov ntshav ntshav yog li 6.2 teev T_1/2 tag nrho cov ntshav metformin yog kwv yees li 17.6 teev, uas qhia tau tsub zuj zuj ntawm ib feem tseem ceeb ntawm cov tshuaj hauv cov ntshav liab.

Cov pab pawg neeg tshwj xeeb

Paul Nws tsis muaj dab tsi cuam tshuam rau cov tshuaj pharmacokinetics ntawm metformin.

Lub siab ua haujlwm tsis zoo. Hauv cov neeg mob uas muaj daim siab tsis txaus, ib qho kev tshawb fawb txog qhov tseeb ntawm cov yam ntxwv ntawm metformin tsis tau ua.

Lub raum khiav tsis zoo. Hauv cov neeg mob uas lub raum lub raum tsis ua haujlwm (raws li ntsuas los ntawm creatinine tshem tawm) T_1/2 metformin los ntawm ntshav ntshav thiab ntshav nce ntxiv, thiab nws cov qog ua kom lub siab poob qis kom muaj kev sib txig sib luag nrog qhov txo qis ntawm creatinine kev ua kom huv.

Cov neeg mob ≥65 xyoo. Raws li kev tshawb fawb pharmacokinetic tsawg, hauv cov neeg noj qab haus huv ≥65 xyoo, muaj qhov txo qis hauv ntshav tag nrho ntawm metformin thiab nce T_1/2 thiab C_max piv nrog rau qhov ntsuas no hauv cov hluas. Cov pharmacokinetics ntawm metformin hauv cov tib neeg laus dua 65 xyoos yog feem ntau cuam tshuam nrog kev hloov pauv ntawm lub raum, thiab vim li no, hauv cov neeg mob laus dua 80 xyoo, Galvus Met tsuas yog ua tau nrog kev siv creatinine zoo li qub.

Cov neeg mob ≤18 xyoo. Cov yam ntxwv ntawm cov tshuaj metformin hauv cov menyuam yaus thiab cov tub ntxhais hluas hnub nyoog qis dua 18 xyoo tsis tau tsim.

Cov neeg mob ntawm ntau haiv neeg. Tsis muaj pov thawj dab tsi cuam tshuam ntawm cov neeg mob cov neeg mob ntawm cov qauv tshuaj pharmacokinetic ntawm metformin. Hauv kev tswj xyuas cov kev tshawb fawb ntawm cov tshuaj metformin hauv cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus ntawm cov haiv neeg sib txawv, cov nyhuv tshuaj tiv thaiv ntshav qab zib tsis raug rau tib yam.

Cov kev tshawb fawb qhia txog kev sib npaug ntawm qhov AUC thiab C_max Galvus Met hauv 3 ntau qhov sib txawv (50 mg + 500 mg, 50 mg + 850 mg thiab 50 mg + 1000 mg) thiab vildagliptin thiab metformin, noj nyob rau hauv cov koob tshuaj tsim nyog hauv cov ntsiav tshuaj txawv.

Noj khoom tsis cuam tshuam rau qib thiab qib ntawm nqus vildagliptin hauv tshuaj sib xyaw Galvus Met. C qhov tseem ceeb_max thiab AUC ntawm metformin hauv kev sib xyaw ntawm cov tshuaj Galvus Met thaum noj nrog zaub mov txo qis los ntawm 26 thiab 7%, feem. Tsis tas li ntawd, tawm tsam keeb kwm ntawm kev noj zaub mov, kev nqus ntawm metformin ua rau qeeb, uas ua rau muaj kev nce hauv T_max (2 txog 4 teev). Zoo li hloov C_max thiab AUC nrog kev ua zaub mov noj kuj tau sau tseg nyob rau hauv kev siv tshuaj metformin cais, txawm li cas los xij, hauv rooj plaub tom kawg, qhov kev hloov pauv tsis tseem ceeb. Cov nyhuv ntawm cov zaub mov ntawm pharmacokinetics ntawm vildagliptin thiab metformin hauv tshuaj muaj pes tsawg leeg Galvus Met tsis txawv ntawm qhov ntawd thaum noj ob qho tshuaj sib cais.

Qhia Txog Galvus Met ®

Hom 2 mob ntshav qab zib mellitus (ua ke nrog kev kho kev noj haus thiab qoj ib ce):

nrog lub txiaj ntsig tsis txaus ntawm kev kho kab mob siab nrog vildagliptin lossis metformin,

hauv cov neeg mob yav tas los tau txais kev kho ua ke nrog vildagliptin thiab metformin ua ib hom tshuaj ib yam,

hauv kev sib xyaw nrog sulfonylurea derivatives (triple integration therapy) hauv cov neeg mob yav tas los kho nrog sulfonylurea derivatives thiab metformin tsis muaj glycemic tswj tau,

nyob rau hauv kev sib koom ua ke peb zaug kev kho mob nrog insulin hauv cov neeg mob yav dhau los tau txais insulin txoj kev kho nyob rau hauv lub zog ruaj khov thiab metformin tsis tau ua tiav kev tswj glycemic,

raws li kev pib kho mob hauv cov neeg mob uas muaj ntshav qab zib hom 2 mob ntshav qab zib nrog kev tsis txaus ntseeg ntawm kev noj zaub mov noj, qoj ib ce thiab xav tau kev txhim kho glycemic tswj.

Cov Yuav Tsum Tau Ua

ua kom txo qis rau vildagliptin lossis metformin lossis lwm yam tshuaj,

lub raum tsis ua hauj lwm los yog lub raum lub raum tsis zoo (nrog rau cov ntshav creatinine concentration ntawm ≥1.5 mg% (> 135 μmol / L) - rau cov txiv neej thiab ≥1.4 mg% (> 110 μmol / L) - rau cov poj niam),

muaj mob hnyav nrog kev pheej hmoo ntawm kev tsim muaj lub raum ua haujlwm: lub cev qhuav dej (nrog rau mob raws plab, ntuav), kub taub hau, mob hnyav kis, mob ntawm hypoxia (poob siab, sepsis, mob raum, kab mob ntsws).

mob plawv thiab mob plawv tsis ua haujlwm, mob myocardial infarction, mob plawv tsis txaus (poob siab), ua tsis taus pa,

lub siab ua tsis taus haujlwm,

mob ntshav qab zib los yog mob ntev ntev (nrog rau ketoacidosis uas mob ntshav qab zib ua ke nrog lossis tsis nco qab lawm), mob ntshav qab zib ketoacidosis (yuav tsum tau kho los ntawm kev kho mob insulin), lactic acidosis (suav nrog keeb kwm),

ua ntej kev phais mob, radioisotope, kev tshawb nrhiav xoo hluav taws xob nrog kev qhia ntawm tus neeg sawv cev sib piv - cov tshuaj tsis raug cai rau 48 teev thiab hauv 48 teev tom qab lawv tau coj,

ntshav qab zib hom 1

haus cawv qaug cawv, qaug cawv lom,

ua raws li kev noj zaub mov kom tsis txhob muaj calories ntau tsawg (tsawg dua 1000 kcal / hnub),

cov menyuam yaus hnub nyoog qis dua 18 xyoo (qhov ua tau zoo thiab kev nyab xeeb tsis pom zoo).

Txij li cov neeg mob uas lub siab tsis ua haujlwm zoo hauv qee kis muaj cov kab mob lactic acidosis, uas tej zaum yog ib qho kev mob tshwm sim ntawm metformin, Galvus Met yuav tsum tsis txhob siv rau cov neeg mob siab lossis lub siab tsis ua haujlwm biochemical ntawm lub siab ua haujlwm.

Nrog saib xyuas: cov neeg mob hnub nyoog laus dua 60 xyoo thaum ua haujlwm lub cev hnyav vim ua rau muaj kev pheej hmoo ntawm cov kab mob lactic acidosis.

Cev xeeb tub thiab lactation

Hauv kev sim tshuaj rau cov tsiaj txhu nrog kev siv vildagliptin hauv koob tshuaj 200 zaug siab dua qhov kev pom zoo, cov tshuaj tsis ua rau muaj kev ua txhaum ntawm kev txhim kho thaum ntxov ntawm lub cev thiab tsis ua qhov cuam tshuam teratogenic. Thaum siv vildagliptin hauv kev sib xyaw nrog metformin hauv qhov sib piv ntawm 1:10, cov nyhuv teratogenic kuj tseem tsis pom.

Txij li tsis muaj cov ntaub ntawv txaus ntawm kev siv tshuaj Galvus Met hauv cov poj niam cev xeeb tub, kev siv cov tshuaj thaum cev xeeb tub yog contraindicated.

Metformin hla mus rau hauv niam cov kua mis. Kuj tsis paub meej tias vildagliptin puas tau tawm hauv cov kua mis. Kev siv cov tshuaj Galvus Met thaum lub sijhawm pub mis niam yog contraindicated.

Sab sij huam

Cov ntaub ntawv hauv qab no cuam tshuam txog kev siv vildagliptin thiab metformin hauv kev kho tshuaj thiab hauv kev sib xyaw.

Raws li kev pom zoo vildagliptin, kev kho lub siab ua haujlwm (suav nrog kab mob siab) tsis tshua pom muaj. Feem ntau, cov kev ua txhaum thiab kev hloov pauv ntawm daim siab ua haujlwm los ntawm qhov tsis xws li tau daws lawv tus kheej yam tsis muaj teeb meem tom qab tsis siv tshuaj kho. Thaum ua ntawv thov vildagliptin ntawm koob tshuaj 50 mg 1 lossis 2 zaug hauv ib hnub, qhov ntau zaus ntawm kev nce siab hauv kev ua haujlwm ntawm daim siab enzymes (ALT lossis ACT 3 zaug siab dua VGN) yog 0.2 lossis 0.3%, ntsig txog (piv nrog 0.2% hauv pawg tswj) Cov. Kev nce ntxiv ntawm cov kev ua haujlwm ntawm daim siab enzymes hauv feem ntau yog asymptomatic, tsis tau nce zuj zus, thiab tsis yog nrog cholestasis lossis jaundice.

Cov txheej txheem hauv qab no tau siv los ntsuas qhov tshwm sim ntawm qhov tshwm sim tsis zoo (AE): feem ntau (/1 / 10), feem ntau (≥1 / 100, GIT), tus lej ntawm AE piv nrog kev kho mob sib xyaw nrog vildagliptin thiab metformin yog 12.9%. soj ntsuam hauv 18.1% ntawm cov neeg mob.

Hauv cov pab pawg ntawm cov neeg mob tau txais cov tshuaj metformin ua ke nrog vildagliptin, mob plab zom mov tau sau tseg nrog zaus ntawm 10-15%, thiab hauv pawg ntawm cov neeg mob tau txais metformin ua ke nrog cov placebo, nrog zaus ntawm 18%.

Cov kev kho mob mus ntev mus txog 2 xyoos tsis qhia txog qhov kev hloov pauv ntxiv hauv cov ntaub ntawv kev nyab xeeb lossis qhov tsis paub txog kev phom sij thaum siv vildagliptin raws li kev kho mob monotherapy.

Kev kawm txog kev siv ntawm kev sib xyaw ntawm vildagliptin thiab metformin ua tus pib kho rau hom 2 ntshav qab zib mellitus tsis tau qhia txog cov kev pheej hmoo thiab cov ntaub ntawv muaj kev nyab xeeb ntxiv.

Kev siv cov vildagliptin ib txhij nrog insulin

Hauv kev tswj cov chaw kho mob nrog kev siv cov vildagliptin ntawm koob tshuaj 50 mg 2 zaug hauv ib hnub hauv tshuaj insulin hauv kev sib xyaw nrog metformin lossis tsis yog nws, qhov ntau zaus tsis cuam tshuam txog kev kho vim tias kev txhim kho kev tsis haum yog 0.3% hauv pawg vildagliptin, thaum nyob hauv pawg placebo. tsis muaj kev tshem tawm txoj kev kho.

Qhov tshwm sim ntawm cov ntshav qog ntshav qab zib tau sib piv hauv ob pawg (14% hauv pawg vildagliptin thiab 16.4% hauv pawg placebo). Hauv pab pawg vildagliptin, cov neeg mob ntshav qabzib ntau tau teev tseg hauv 2 tus neeg mob, hauv cov pab pawg placebo - hauv 6.

Thaum lub sijhawm kawm tiav, cov tshuaj tsis cuam tshuam rau qhov nruab nrab lub cev qhov hnyav (lub cev qhov hnyav nce 0.6 kg piv rau cov qub hauv pawg vildagliptin, thiab tsis muaj kev hloov pauv hauv cov pawg placebo).

AEs hauv cov neeg mob tau txais vildagliptin 50 mg 2 zaug hauv ib hnub hauv kev sib xyaw nrog insulin (nrog lossis tsis muaj metformin) yog qhia hauv qab no.

Los ntawm lub paj hlwb: feem ntau mob taub hau.

Los ntawm cov hnyuv: feem ntau - xeev siab, mob lub plab zom mov tsis haum, tso tsis tu ncua - raws plab, mob plab.

Los ntawm sab ntawm cov metabolism thiab khoom noj khoom haus: feem ntau - hypoglycemia.

Kev cuam tshuam dav dav thiab cuam tshuam ntawm qhov chaw txhaj tshuaj: feem ntau - ua daus no.

Thaum siv vildagliptin txuam nrog sulfonylurea npaj

Cov xwm txheej ntawm kev txiav tawm yeeb tshuaj cuam tshuam nrog kev txhim kho ntawm AE nyob rau hauv kev sib koom tes kho pab pawg nrog vildagliptin, metformin thiab glimepiride tsis tau sau tseg. Hauv kev kho ua ke ntawm cov tshuaj placebo, metformin thiab glimepiride, qhov tshwm sim ntawm AE yog 0.6%.

Hypoglycemia feem ntau pom nyob hauv ob pawg (5.1% hauv kev sib koom ua ke nrog pawg vildagliptin, metformin thiab glimepiride thiab 1.9% hauv kev sib koom ua ke nrog pawg nrog placebo, metformin thiab glimepiride). Hauv pawg vildagliptin, ib qho xwm txheej ntawm cov ntshav qog ntshav qab zib hnyav tau sau tseg.

Thaum lub sijhawm txoj kev tshawb fawb tiav, tsis muaj qhov cuam tshuam loj rau lub cev qhov hnyav (+0.6 kg hauv pawg vildagliptin thiab −0.1 kg hauv cov pab pawg placebo).

AEs hauv cov neeg mob tau txais vildagliptin 50 mg 2 zaug hauv ib hnub hauv kev sib xyaw nrog metformin thiab sulfonylureas tau nthuav tawm hauv qab no.

Los ntawm lub paj hlwb: feem ntau - kiv taub hau, tshee co.

Kev cuam tshuam dav dav thiab cuam tshuam ntawm qhov chaw txhaj tshuaj: feem ntau qaug zog.

Los ntawm sab ntawm cov metabolism thiab khoom noj khoom haus: feem ntau - hypoglycemia.

Ntawm ib feem ntawm daim tawv nqaij thiab cov nqaij mos subcutaneous: feem ntau - hyperhidrosis.

Thaum siv vildagliptin li monotherapy

Los ntawm lub paj hlwb: feem ntau - kiv taub hau, tsis xws luag - mob taub hau.

Los ntawm cov hnyuv: ncaw - cem quav.

Ntawm ib feem ntawm daim tawv nqaij thiab cov nqaij mos subcutaneous: ua tsis tau - ua pob khaus tawv.

Los ntawm sab hauv ntawm cov leeg thiab cov leeg nqaij txuas: feem ntau - arthralgia.

Kev cuam tshuam dav dav thiab cuam tshuam ntawm qhov chaw txhaj tshuaj: tsis nkag siab - peripheral edema.

Thaum siv kev sib xyaw ua ke nrog vildagliptin thiab metformin, qhov kev kuaj mob tseem ceeb nce rau hauv cov zaus ntawm AEs saum toj no tau sau tseg nrog vildagliptin tsis tau pom.

Nyob rau keeb kwm yav dhau los ntawm kev kho mob monotherapy nrog vildagliptin lossis metformin, qhov tshwm sim ntawm kev mob ntshav qab zib yog 0.4% (ua haujlwm tsis dhau).

Kev kho mob monotherapy nrog vildagliptin thiab kev sib xyaw ua ke ntawm vildagliptin + metformin tsis cuam tshuam rau tus neeg mob lub cev qhov hnyav.

Cov kev mob tshwm sim hauv qab no tau txheeb pom nyob rau lub sijhawm tom qab tau tshaj tawm (txij li cov ntaub ntawv tau tshaj tawm los ntawm kev tuaj yeem ntawm cov neeg tsis muaj hnub nyoog, nws tsis tuaj yeem ntseeg tau txiav txim siab qhov ntau zaus ntawm txoj kev loj hlob ntawm cov AEs, thiab yog li ntawd lawv tau muab cais raws li qhov tsis paub ntau npaum li cas): kab mob siab (rov qab thaum kho tsis nres), urticaria, mob txhab kiav txhab, tawv nqaij thiab tawv nqaij zoo nkauj.

Thaum siv metformin hauv kev kho tshuaj

Los ntawm sab ntawm cov metabolism thiab khoom noj khoom haus: ntau zaus - tsis qab los, tsis tshua muaj tshwm sim - lactic acidosis.

Los ntawm cov hnyuv: heev ntau - flatulence, xeev siab, ntuav, raws plab, mob plab, feem ntau - dysgeusia.

Nyob rau ib feem ntawm daim siab thiab kais plab: tsawg kawg - kab mob siab.

Ntawm ib feem ntawm daim tawv nqaij thiab cov nqaij mos subcutaneous: tsis tshua muaj tshwm sim - kev hloov tawv nqaij tawv nqaij (tshwj xeeb erythema, mob pruritus, urticaria).

Kuaj thiab ntsuas cov ntaub ntawv: tsis tshua muaj neeg - txo kev nqus ntawm vitamin B₁₂, hloov pauv hauv daim siab ua haujlwm qhov taw qhia.

Kev txo qis Vitamin B Txo₁₂ thiab qhov kev txo qis hauv nws qhov kev mob siab hauv cov ntshav cov ntshav nrog kev siv cov metformin tau pom tias muaj tsawg kawg hauv cov neeg mob tau txais tshuaj rau lub sijhawm ntev, thiab, raws li txoj cai, tsis sawv cev rau qhov tseem ceeb hauv chaw kho mob. Kev txiav txim siab yuav tsum muab rau kev txo qis nqus cov vitamin B₁₂ hauv cov neeg mob megaloblastic anemia.

Qee kis ntawm tus kab mob siab, uas tau pom nrog kev siv tshuaj metformin, tau daws tom qab nws tshem tawm.

Kev sib txuam

Nrog rau kev siv vildagliptin (100 mg 1 zaug hauv ib hnub) thiab metformin (1000 mg 1 zaug hauv ib hnub), PCF tseem ceeb qhov chaw kuaj mob tsis pom ntawm lawv. Tsis yog thaum lub sijhawm sim tshuaj, lossis thaum lub sijhawm siv dav dav Galvus Met hauv cov neeg mob uas tau txais tib lub sijhawm sib xyaw nrog lwm cov tshuaj thiab cov yeeb tshuaj, kev sib cuam tshuam tsis tau pom tsis pom.

Vildagliptin muaj qhov tsis tshua zoo rau kev sib txuam tshuaj. Txij li thaum vildagliptin tsis yog lub zog ntawm cytochrome P450 enzymes, tsis yog nws inhibit lossis ntxias cov isoenzymes no, nws cov kev cuam tshuam nrog tshuaj uas yog cov substrates, inhibitors, lossis P450 inducers tsis zoo li. Nrog rau kev siv vildagliptin ib txhij tsis cuam tshuam rau qhov tshuaj ntawm cov tshuaj uas hloov cov enzymes: CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 thiab CYP3A4 / 5.

Qhov sib cuam tshuam ntawm chaw mob muaj vildagliptin nrog cov tshuaj feem ntau siv hauv kev kho mob hom 2 mob ntshav qab zib mellitus (glibenclamide, pioglitazone, metformin) lossis muaj kev kho mob me me (amlodipine, digoxin, ramipril, simvastatin, valsartan, warfarin) tseem tsis tau tsim.

Furosemide nce C_max thiab AUC ntawm metformin, tab sis tsis cuam tshuam rau nws lub raum kev ntshiab. Metformin txo qis C_max thiab AUC ntawm furosemide thiab kuj tsis cuam tshuam rau nws lub raum sab hauv.

Nifedipine nce kev nqus, C_max thiab AUC ntawm metformin, ntxiv rau, nws tsub kom nws cov zis tawm los ntawm lub raum. Metformin kev coj ua tsis cuam tshuam rau qhov kev txiav txim ntawm nifedipine.

Glibenclamide tsis cuam tshuam rau qhov chaw muag tshuaj / chaw muag tshuaj ntawm metformin. Metformin feem ntau txo qis C_max thiab AUC ntawm glibenclamide, txawm li cas los xij, qhov ntau ntawm cov nyhuv txawv heev. Vim li no, qhov tseem ceeb kho mob ntawm qhov kev sib txuam no tseem tsis meej.

Organic cationspiv txwv li, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamteren, trimethoprim, vancomycin thiab lwm tus, raug zam los ntawm lub raum los ntawm tubular tso pa, tuaj yeem theoretically cuam tshuam nrog metformin vim yog kev sib tw rau ib qho kev ua haujlwm ntawm cov leeg tub hlab ntsha thauj. Yog li, cimetidine tsub kom ob qho tib si cov concentration ntawm metformin hauv ntshav ntshav thiab nws AUC los ntawm 60 thiab 40%, feem. Metformin tsis cuam tshuam rau qhov kev siv pharmacokinetic ntawm cimetidine. Ceev faj yuav tsum tau siv thaum siv Galvus Met nrog rau cov tshuaj uas cuam tshuam rau lub raum kev ua haujlwm lossis kev faib tawm ntawm metformin hauv lub cev.

Lwm yam tshuaj. Qee cov tshuaj muaj peev xwm ua rau hyperglycemia thiab txo qis qhov ua haujlwm ntawm cov kab mob ntshav qab zib tsawg. Cov tshuaj no suav nrog thiazides thiab lwm cov tshuaj diuretics, GCS, phenothiazines, kev npaj tshuaj thyroid, estrogens, tshuaj tiv thaiv qhov ncauj, phenytoin, nicotinic acid, sympathomimetics, calcium antagonists thiab isoniazid. Nrog rau kev siv cov tshuaj ib txhij los yog, ntawm qhov tsis sib thooj, yog tias lawv tshem tawm, nws raug nquahu kom ua tib zoo saib xyuas qhov ua tau zoo ntawm metformin (nws cov nyhuv hauv hypoglycemic) thiab, yog tias tsim nyog, kho qhov tshuaj ntawm cov tshuaj. Concomitant siv tsis pom zoo danazole txhawm rau kom zam dhau kev ua hyperglycemic ntawm tom kawg. Yog tias kev kho mob nrog danazol yog qhov tsim nyog thiab tom qab tso tseg kev tswj hwm ntawm tom kawg, kev kho tshuaj metformin yuav tsum ua raws li kev tswj hwm ntawm cov ntshav qabzib concentration.

Chlorpromazine thaum siv cov koob tshuaj loj (100 mg ib hnub twg), nws nce glycemia, txo qis kev tawm ntawm insulin. Hauv kev kho tshuaj tiv thaiv kev tiv thaiv thiab tom qab txiav tom qab kawg, kev kho tshuaj ntawm tshuaj Galvus Met yuav tsum tau nyob hauv kev tswj hwm ntawm cov ntshav qabzib concentration.

Cov tshuaj tiv thaiv radiopaque Iodine: kev tshawb nrhiav radiological siv cov tshuaj iodine-muaj radiopaque tuaj yeem ua rau kev txhim kho ntawm cov kab mob lactic acidosis hauv cov neeg mob ntshav qab zib mellitus nrog kev ua haujlwm lub raum tsis ua haujlwm.

Txhaj β₂sympathomimetics: nce glycemia vim kev ua tiav ntawm β₂-adrenoreceptors. Hauv qhov no, glycemic tswj yog tsim nyog. Yog tias tsim nyog, insulin raug pom zoo.

Nrog tib lub sijhawm siv cov metformin nrog sulfonylurea derivatives, insulin, acarbose, salicylates, nce ntxiv ntawm cov nyhuv hypoglycemic yog ua tau.

Txij li thaum siv cov metformin hauv cov neeg mob haus cawv ntau dhau los ua rau muaj kev phom sij lactic acid (tshwj xeeb tshaj yog lub sijhawm tshaib plab, qaug zog, lossis lub siab tsis ua haujlwm), hauv kev kho mob nrog Galvus Met, koj yuav tsum tsis txhob haus cawv thiab tshuaj muaj cawv uas muaj cov tshuaj muaj yees ethyl.

Tsuas tshuaj thiab tswj hwm

Qhov ntau npaum ntawm qhov tshuaj ntawm Galvus Met yuav tsum tau xaiv ib tus zuj zus, nyob ntawm seb qhov ua tau zoo thiab kev siv tshuaj kho tau. Thaum siv Galvus Met, tsis txhob siab tshaj qhov pom zoo tshaj plaws txhua hnub koob tshuaj vildagliptin (100 mg).

Qhov kev pom zoo yuav pib ntawm Galvus Met yuav tsum tau xaiv, coj mus rau hauv tus lej ntawm lub sijhawm ntawm cov chav kawm mob ntshav qab zib thiab theem ntawm glycemia, tus neeg mob tus mob thiab kev kho mob ntawm vildagliptin thiab / lossis metformin twb tau siv hauv tus neeg mob. Txo kom txo qhov txaus ntshai ntawm kev phiv los ntawm cov hnyuv hauv plab, tus yam ntxwv ntawm metformin, Galvus Met noj nrog zaub mov.

Thawj koob tshuaj ntawm Galvus Met nrog qhov tsis muaj txiaj ntsig ntawm kev kho ntshav nrog vildagliptin

Kev kho mob tuaj yeem pib nrog 1 ntsiav tshuaj. (50 mg + 500 mg) 2 zaug hauv ib hnub, tom qab tshuaj xyuas cov nyhuv kho, qhov koob tshuaj yuav maj mam nce ntxiv.

Thawj koob tshuaj ntawm Galvus Met nrog kev ua tsis tiav ntawm kev kho mob monotherapy nrog metformin

Nyob ntawm seb cov koob tshuaj uas tau noj cov tshuaj metformin, kev kho mob nrog Galvus Met tuaj yeem pib nrog 1 ntsiav tshuaj. (50 mg + 500 mg, 50 mg + 850 mg lossis 50 mg + 1000 mg) 2 zaug hauv ib hnub.

Thawj koob tshuaj ntawm Galvus Met nyob rau hauv cov neeg mob yav tas los tau txais kev kho ua ke nrog vildagliptin thiab metformin hauv daim ntawv ntawm cais cov ntsiav tshuaj

Nyob ntawm cov koob tshuaj vildagliptin lossis metformin uas twb tau noj lawm, kev kho mob nrog Galvus Met yuav tsum tau pib ntawm cov ntsiav tshuaj uas ze rau qhov ntau npaum li cas ntawm kev noj tshuaj ntawm cov kev kho mob uas twb muaj lawm (50 mg + 500 mg, 50 mg + 850 mg lossis 50 mg + 1000 mg), thiab kho qhov koob tshuaj rau nyob ntawm cov hauj lwm zoo.

Thawj koob tshuaj Galvus Met ua qhov pib pabcuam rau cov neeg mob ntshav qab zib hom 2 ntshav qab zib tsis muaj txiaj ntsig ntawm kev noj zaub mov zoo thiab kev tawm dag zog

Raws li pib txoj kev kho mob, Galvus Met yuav tsum tau sau tseg rau hauv koob tshuaj 50 mg + 500 mg ib hnub ib zaug, thiab tom qab tshuaj xyuas cov txiaj ntsig kho, maj mam nce qhov koob tshuaj rau 50 mg + 1000 mg 2 zaug hauv ib hnub.

Kev sib xyaw ua ke nrog Galvus Met thiab sulfonylurea derivatives lossis insulin

Cov koob tshuaj ntawm Galvus Met yog suav raws li kev txhaj tshuaj ntawm vildagliptin 50 mg × 2 zaug hauv ib hnub (100 mg rau ib hnub) thiab metformin hauv ib koob tshuaj sib npaug rau cov uas tau noj yav tas los ua ib cov tshuaj.

Cov pab pawg neeg tshwj xeeb

Lub raum khiav tsis zoo. Hauv cov neeg mob uas lub raum tsis ua haujlwm, koob tshuaj nrog Cl creatinine (xam los ntawm tus qauv Cockcroft-Gault) hauv thaj tsam li 60 txog 90 ml / min kuj yuav tsum tau ua. Kev siv cov tshuaj Galvus Met hauv cov neeg mob nrog Cl creatinine VGN 2 zaug). Nrog rau qhov nce ntxiv ntawm koob tshuaj vildagliptin mus rau 600 mg / hnub, kev txhim kho ntawm edema ntawm qhov kawg yog ua tau, nrog los ntawm paresthesias thiab kev nce ntxiv hauv kev ua kom zoo ntawm CPK, C-reactive protein thiab myoglobin, thiab AST kev ua si. Tag nrho cov tsos mob ntawm kev haus ib ce thiab hloov cov kev hloov hauv chaw kuaj ploj tom qab tsis siv tshuaj.

Kev Kho Mob: tshem tawm cov tshuaj ntawm lub cev los ntawm kev lim ntshav yog qhov tsis zoo. Txawm li cas los xij, lub ntsiab hydrolytic metabolite ntawm vildagliptin (LAY151) tuaj yeem tshem tawm hauv lub cev los ntawm hemodialysis.

Cov tsos mob ob peb kis ntawm kev haus ntau tshaj ntawm metformin, suav nrog raws li kev noj haus kev haus tshuaj nyob rau hauv qhov nyiaj ntau tshaj 50 g. Nrog kev noj tshuaj ntau dua ntawm metformin, kev mob ntshav qab zib tau pom nyob hauv kwv yees li 10% ntawm tus neeg mob (txawm li cas los xij, nws txoj kev sib raug zoo nrog cov tshuaj tsis tau tsim). Hauv 32% ntawm cov neeg mob, lactic acidosis tau sau tseg. Cov tsos mob thaum ntxov ntawm tus kab mob lactic acid yog xeev siab, ntuav, raws plab, qhov kub cev tsawg, mob plab, mob leeg, thiab yuav muaj kev ua pa ntxiv, kiv taub hau, tsis meej pem thiab tsis nco qab lawm.

Kev Kho Mob: cov tsos mob, raws li tus neeg mob lub mob thiab cov chaw kuaj mob. Nws raug tshem tawm los ntawm cov ntshav siv hemodialysis (nrog kev tshem tawm kom txog li ntawm 170 ml / min) tsis muaj kev txhim kho hemodynamic kev puas tsuaj. Yog li, hemodialysis tuaj yeem siv los tshem tawm cov tshuaj metformin los ntawm cov ntshav thaum muaj tshuaj ntau dhau.

Cov lus qhia tshwj xeeb

Hauv cov neeg mob uas tau txais insulin, Galvus Met tsis tuaj yeem hloov cov tshuaj insulin.

Lub siab ua haujlwm tsis zoo. Txij li thaum thov vildagliptin, kev nce ntxiv ntawm kev ua si ntawm aminotransferases (feem ntau tsis muaj kev kho mob hauv cov chaw kho mob) tau sau tseg qee zaus ntau dua li pawg tswj hwm, nws raug nquahu kom txiav txim siab txog biochemical cov kev ua haujlwm ntawm daim siab ua haujlwm ua ntej siv tshuaj Galvus Met, zoo li tsis tu ncua thaum kho. Yog tias qhov nce ntawm kev ua haujlwm ntawm aminotransferases raug tshawb pom, ib qho kev tshawb nrhiav kev tshawb fawb yuav tsum tau nqa tawm thiaj li paub meej tias qhov tshwm sim, thiab tom qab ntawd ua ntu zus los txiav txim siab cov biochemical tsis ua haujlwm ntawm daim siab ua haujlwm kom txog thaum lawv ua haujlwm. Yog tias qhov dhau ntawm AST lossis ALT kev ua haujlwm yog 3 lossis ntau dua lub sijhawm ntau dua li VGN tau lees paub los ntawm kev tshawb fawb tshawb, nws raug nquahu kom thim cov tshuaj.

Cov kab mob lactic acidosis. Cov kab mob lactic acidosis yog ib qho mob uas tsis tshua pom tshwm sim ntau tab sis hnyav uas tshwm sim nrog kev txuam nrog metformin hauv lub cev. Lactate acidosis nrog kev siv cov metformin tau raug soj ntsuam tsuas yog nyob hauv cov neeg mob ntshav qab zib mellitus uas muaj kev puas tsuaj rau lub raum. Txoj kev pheej hmoo ntawm kev tsim mob lactic acidosis nce ntxiv hauv cov neeg mob uas tsis muaj peev xwm kho tau tus mob ntshav qab zib mellitus, nrog ketoacidosis, kev tshaib plab ntev ntev, kev haus dej cawv ntau, ua rau lub siab ua haujlwm thiab cov kab mob uas ua rau hypoxia.

Nrog rau kev txhim kho ntawm cov kab mob lactic acidosis, ua pa luv, mob plab thiab mob hypothermia, tom qab los ntawm coma, tau sau tseg. Qhov ntsuas pom hauv qab no muaj cov kev kuaj mob: qhov txo qis hauv cov ntshav pH, qhov nce ntawm lactate hauv cov ntshav dej siab tshaj 5 nmol / L, nrog rau qhov nce ntawm anionic interval thiab nce piv ntawm lactate / pyruvate. Yog tias xav tias cov tshuaj lactic acidosis tsis ntseeg, cov tshuaj yuav tsum tsis ua ntxiv thiab tus neeg mob pw hauv tsev kho mob tam sim ntawd.

Saib xyuas raum muaj nuj nqi. Txij li metformin feem ntau ua rau lub raum tawm, qhov kev pheej hmoo ntawm nws cov tsub zuj zuj thiab kev loj hlob ntawm cov kab mob lactic acid nce ntxiv hauv kev faib ua feem rau qhov mob tsis zoo ntawm lub raum tsis ua haujlwm. Thaum siv tshuaj, Galvus Met yuav tsum soj ntsuam lub raum kev ua haujlwm tsis tu ncua, tshwj xeeb tshaj yog nyob rau hauv cov xwm txheej uas ua rau nws ua txhaum, xws li thawj theem pib ntawm kev kho mob nrog cov tshuaj tiv thaiv kab mob, hypoglycemic agents lossis NSAIDs. Lub raum kev ua haujlwm yuav tsum raug ntsuas ua ntej pib kho nrog Galvus Met, thiab tom qab ntawd tsawg kawg 1 zaug nyob rau ib xyoos hauv cov neeg mob lub raum zoo dua qub thiab tsawg kawg 2-4 zaug hauv ib xyoo hauv cov neeg mob uas muaj creatinine tshem tawm ntawm qhov qis dua, nrog rau cov neeg laus cov neeg mob. Hauv cov neeg mob uas muaj qhov pheej hmoo loj ntawm lub raum khiav tsis zoo, kev soj ntsuam yuav tsum tau ua ntau dua 2 times4 zaug hauv ib lub xyoo. Yog tias pom tias lub raum ua tsis muaj zog tshwm sim, Galvus Met yuav tsum tsis ua mus ntxiv.

Kev siv cov tshuaj iodine uas muaj cov kab mob radiopaque rau kev tswj hwm intravascular. Thaum ua kev tshawb nrhiav xoo hluav taws xob uas yuav tsum muaj kev tswj hwm intravascular ntawm iodine-muaj cov kab mob radiopaque, Galvus Met yuav tsum tau txiav tawm ib ntus (48 teev ua ntej, thiab tseem nyob rau hauv 48 teev tom qab kev tshawb fawb), txij li intravascular tswj hwm ntawm iodine-muaj radiopaque cov neeg sawv cev tuaj yeem ua rau lub cev tsis zoo hauv lub raum ua haujlwm thiab nce kev pheej hmoo ntawm cov kab mob lactic acidosis. Txhawm rau rov qab noj cov tshuaj Galvus Met ua raws nkaus xwb tom qab kev tshuaj ntsuam xyuas dua ntawm kev ua haujlwm lub raum.

Kev Hypoxia. Hauv cov mob plawv tsis ua haujlwm (poob siab), mob plawv tsis ua haujlwm, mob myocardial infarction thiab lwm yam mob uas muaj los ntawm hypoxia, kev txhim kho ntawm cov kab mob lactic acidosis thiab prerenal mob raum tsis ua haujlwm tau. Yog tias cov xwm txheej saum toj no tshwm sim, cov tshuaj yuav tsum tau txiav tam sim ntawd.

Kev phais mob. Thaum muaj kev cuam tshuam txog kev phais mob (tshwj tsis yog muaj kev ua haujlwm me me uas tsis cuam tshuam txog kev txwv cov zaub mov thiab kua dej), cov tshuaj Galvus Met yuav tsum tau txiav tawm. Kev rov pib siv cov tshuaj muaj peev xwm tau tom qab kho kom rov qab los ntawm kev noj zaub mov hauv qhov ncauj hauv cov neeg mob uas tsis muaj qhov cuam tshuam uas tsis zoo lub raum.

Haus cawv. Nws tau pom tias haus cawv ntxiv cov nyhuv ntawm metformin ntawm lactate metabolism. Cov neeg mob yuav tsum tau ceeb toom txog qhov tsis muaj cai ntawm kev haus cawv thaum lub sijhawm siv cov tshuaj Galvus Met.

Deterioration hauv cov neeg mob uas muaj ntshav qab zib hom 2 uas yav dhau los tau teb rau txoj kev kho. Yog tias kuaj pom qhov txawv txav ntawm cov cai tau kuaj pom lossis cov tsos mob hauv tsev kho mob pom tias tus mob feem ntau zuj zus (tshwj xeeb tshaj yog muaj qhov qhia tsis meej thiab qhov muag plooj) hauv cov neeg mob uas tau txais kev kho mob ua ntej, kev kuaj mob yuav tsum tau ua tam sim ntawd txhawm rau kuaj ketoacidosis thiab / lossis lactic acidosis. Yog tias kuaj pom tus mob acidosis, koj yuav tsum tsis txhob siv tshuaj tam sim ntawd thiab ntsuas kev tsim nyog los kho tus neeg mob tus mob.

Kev ntshav siab. Feem ntau, hauv cov neeg mob uas tau txais tsuas yog Galvus Met, tsis muaj ntshav qab zib tsis tau tiv thaiv, tab sis nws tuaj yeem tshwm sim tawm tsam ntawm cov zaub mov tsis muaj calorie tsawg (thaum muaj lub cev ua si tsis tau them nyiaj los ntawm cov ntsiab lus hauv calorie ntawm cov zaub mov) lossis tiv thaiv keeb kwm ntawm kev haus cawv. Kev txhim kho ntawm cov ntshav qog nqaij hlav feem ntau yog rau cov neeg laus, debilitated lossis tshem tawm cov neeg mob, nrog rau kev tiv thaiv ntawm cov keeb kwm yav dhau los ntawm hypopituitarism, adrenal tsis txaus lossis haus dej cawv. Hauv cov neeg mob laus thiab cov uas tau txais β-blockers, kev kuaj mob ntshav qab zib yog qhov nyuaj.

Kev txo qis qis ntawm kev ua haujlwm ntawm hypoglycemic. Hauv kev ntxhov siab (suav nrog kev ua npaws, mob, mob, phais mob), txhim kho hauv cov neeg mob uas tau txais cov tshuaj hypoglycemic raws li tus qauv txheej txheem, qhov txo qis ntawm cov txiaj ntsig ntawm qhov kawg ntawm qee lub sijhawm yog ua tau. Hauv qhov no, nws yuav tsim nyog txuas mus ib ntus tsis siv tshuaj Galvus Met thiab kev kho tshuaj insulin. Kev rov pib dua ntawm kev kho mob nrog Galvus Met yog tau tom qab xaus lub sijhawm mob.

Cuam Tshuam. Hauv kev sim tshuaj rau cov tsiaj, kev siv vildagliptin hauv koob tshuaj 200 zaug siab dua qhov kev pom zoo tsis ua rau muaj qhov tsis taus.

Tsis muaj qhov tshwm sim tsis zoo rau kev muaj menyuam hauv txivneej thiab pojniam nrog kev siv cov tshuaj metformin ntawm 600 mg / kg / hnub, uas yog kwv yees li 3 zaug siab dua cov koob tshuaj pom zoo rau tib neeg (thaum hloov mus rau lub cev thaj tsam hauv av). Ib txoj kev tshawb nrhiav txog cov nyhuv ntawm tib neeg kev muaj peev xwm tsis tau ua.

Cuam Tshuam rau kev muaj peev xwm tsav tsheb thiab ua haujlwm nrog tshuab. Qhov cuam tshuam ntawm Galvus Met ntawm kev muaj peev xwm tsav tsheb thiab lub tswv yim tsis tau kawm. Nrog rau kev txhim kho kiv taub hau tiv thaiv keeb kwm yav dhau los ntawm kev siv yeeb tshuaj, ib qho yuav tsum tsis kam tsav tsheb thiab lub tswv yim.